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Document 32024R0197

Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances

C/2023/6928

OJ L, 2024/197, 05.01.2024, ELI: http://data.europa.eu/eli/reg_del/2024/197/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg_del/2024/197/oj

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Official Journal
of the European Union

EN

Series L


2024/197

5.1.2024

COMMISSION DELEGATED REGULATION (EU) 2024/197

of 19 October 2023

amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (1), and in particular Article 37(5) thereof,

Whereas:

(1)

Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals to introduce harmonised classification and labelling of certain substances and to update the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (the ‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment of the Agency (RAC) adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:

Opinion of 18 March 2021 concerning benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate;

Opinion of 18 March 2021 concerning benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1);

Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1);

Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1);

Opinion of 18 March 2021 concerning 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF;

Opinion of 18 March 2021 concerning cinnamaldehyde; 3-phenylprop-2-enal; cinnamic aldehyde; cinnamal [1], (2E)-3-phenylprop-2-enal [2];

Opinion of 18 March 2021 concerning benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine;

Opinion 18 March 2021 concerning 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate;

Opinion of 18 March 2021 concerning foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea;

Opinion of 18 March 2021 concerning ethyl acrylate;

Opinion of 18 March 2021 concerning methyl acrylate;

methyl propenoate;

Opinion of 18 March 2021 concerning methyl methacrylate; methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate;

Opinion of 18 March 2021 concerning transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;

Opinion of 18 March 2021 concerning allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester;

Opinion of 18 March 2021 concerning mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride;

Opinion of 10 June 2021 concerning triethylamine;

Opinion of 10 June 2021 concerning di-n-butylamine;

Opinion of 10 June 2021 concerning 4-nitrosomorpholine;

Opinion of 10 June 2021 concerning difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether;

Opinion 10 June 2021 concerning N,N-dimethyl-p-toluidine;

Opinion of 10 June 2021 concerning potassium chlorate;

Opinion of 10 June 2021 concerning sodium chlorate;

Opinion of 10 June 2021 Concerning reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane;

Opinion of 10 June 2021 concerning metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one;

Opinion 16 September 2021 concerning lithium carbonate [1] lithium chloride [2] lithium hydroxide [3];

Opinion of 16 September 2021 concerning dimethyl propylphosphonate;

Opinion of 16 September 2021 concerning dibutyltin maleate;

Opinion of 16 September 2021 concerning dibutyltin oxide;

Opinion of 16 September 2021 concerning clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine;

Opinion of 16 September 2021 concerning cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide;

Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with average molecular weight < 352 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 352 g/mol ≤ average molecular weight < 704 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 704 g/mol ≤ average molecular weight ≤ 1 540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

Opinion of 16 September 2021 concerning 1-phenylethan-1-one (1-phenylethylidene)hydrazone;

Opinion of 16 September 2021 concerning 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride; Basic Red 1;

Opinion of 16 September 2021 concerning picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide;

Opinion of 16 September 2021 concerning diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea;

Opinion of 16 September 2021 concerning diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide;

Opinion of 16 September 2021 concerning hydrogen sulphide, hydrogen sulfide;

Opinion of 16 September 2021 concerning benzyl alcohol;

Opinion of 16 September 2021 concerning resorcinol; 1,3-benzenediol;

Opinion of 16 September 2021 concerning 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A;

Opinion of 16 September 2021 concerning a reassessment at the request of the Commission to review the harmonised classification of lead (environment);

Opinion of 26 November 2021 concerning 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol;

Opinion of 26 November 2021 concerning 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol;

Opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, N,N’-diphenyl-p-phenylene diamine and N,N’-di-o-tolyl-phenylene diamine;

Opinion of 26 November 2021 concerning tetramethylene dimethacrylate;

Opinion of 26 November 2021 concerning 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate;

Opinion of 26 November 2021 concerning 2,2'-ethylenedioxydiethyl dimethacrylate;

Opinion of 26 November 2021 concerning bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate;

Opinion of 26 November 2021 concerning 4-methylimidazole;

Opinion of 26 November 2021 concerning sulfur dioxide;

Opinion of 26 November 2021 concerning 1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one;

Opinion of 26 November 2021 concerning benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate.

(3)

The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. and in the RAC opinion of 16 September 2021 concerning dibutyltin oxide. The additional information has been assessed and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. It is therefore appropriate to introduce the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions.

(4)

The RAC opinion of 16 September 2021 concerning the environmental toxicity of lead put forward various possible options to update the harmonised classification of lead for aquatic toxicity. These options give the possibility to either have a single entry for both lead in powder form (‘lead powder’) and in massive form (‘lead massive’) or to keep two separate entries, one for each form. However, as data for lead massive indicates a lower dissolution in water than for lead powder, a calculation in accordance with Part 4 of Annex I to Regulation (EC) No 1272/2008 leads to a less severe classification for lead massive. It is therefore appropriate to amend the existing aquatic toxicity classification for lead powder with regard to the M-factor and to introduce a different aquatic toxicity classification for lead massive.

(5)

In light of the RAC opinions, it is therefore appropriate to introduce or update the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessments.

(6)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(7)

As regards the classification of methyl methacrylate as a respiratory sensitiser and the classification of lithium carbonate, lithium chloride and lithium hydroxide as reproductive toxic substances the Commission has received additional information from stakeholders after obtaining the RAC opinions of 18 March 2021 and of 16 September 2021 respectively concerning those substances. Since that new scientific information requires further assessment by RAC, methyl methacrylate, lithium carbonate, lithium chloride and lithium hydroxide recommended in the RAC opinions should not be subject to harmonised classification and labelling at this stage.

(8)

Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,

HAS ADOPTED THIS REGULATION:

Article 1

Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2025.

However, suppliers may already before that date classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 October 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 353, 31.12.2008, p. 1.

(2)  The opinions are accessible via the following website: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadlineTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.The opinion of 16 September 2021 concerning a reassessment at the request of the Commission is accessible via the following website: https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment/opinions-of-the-rac-adopted-under-specific-echa-s-executive-director-requests.


ANNEX

In Annex VI to Regulation (EC) No 1272/2008, Table 3 of Part 3 is amended as follows:

(1)

the following entries are inserted following the order of the index numbers corresponding to each entry:

Index No

Chemical Name

EC No

CAS No

Classification

Labelling

Specific Conc. Limits, M- factors and ATE

Notes

Hazard Class and Category Code(s)

Hazard statement Code(s)

Pictogram, Signal Word Code(s)

Hazard statement Code(s)

Suppl. Hazard statement Code(s)

‘015-204-00-5

benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate

479-100-5

577705-90-9

Repr. 1B

H360F

GHS08

Dgr

H360F’

 

 

 

‘015-205-00-0

benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)

278-305-5

75768-65-9

Repr. 1B

H360F

GHS08

Dgr

H360F’

 

 

 

‘015-206-00-6

reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1)

Repr. 1B

H360F

GHS08

Dgr

H360F’

 

 

 

‘015-207-00-1

reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1)

Repr. 1B

H360F

GHS08

Dgr

H360F’

 

 

 

‘015-208-00-7

dimethyl propylphosphonate

242-555-3

18755-43-6

Muta. 1B

Repr. 1B

H340

H360Df

GHS08

Dgr

H340

H360Df’

 

 

 

‘050-034-00-5

dibutyltin maleate

201-077-5

78-04-6

Muta. 2

Repr. 1B

Acute Tox. 2

Acute Tox. 4

STOT RE 1

Skin Corr. 1

Eye Dam. 1

H341

H360FD

H330

H302

H372 (immune system)

H314

H318

GHS08

GHS06

GHS05

Dgr

H341

H360FD

H330

H302

H372 (immune system)

H314

 

inhalation:

ATE = 0,317 mg/L (dusts or mists)

oral:

ATE = 510 mg/kg bw’

 

‘050-035-00-0

dibutyltin oxide

212-449-1

818-08-6

Muta. 2

Repr. 1B

Acute Tox. 3

STOT RE 1

Skin Irrit. 2

Eye Dam. 1

H341

H360FD

H301

H372 (immune system)

H315

H318

GHS08

GHS06

GHS05

Dgr

H341

H360FD

H301

H372 (immune system)

H315

H318

 

oral:

ATE = 170 mg/kg bw’

 

‘603-244-00-1

reaction mass of 1-(2,3-epoxypropoxy)–2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane

Muta. 2

Repr. 1B

H341

H360F

GHS08

Dgr

H341

H360F’

 

 

 

‘603-245-00-7

2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol

221-665-5

3179-89-3

Skin Sens. 1

H317

GHS07

Wng

H317’

 

 

 

‘603-246-00-2

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

211-477-1

647-42-7

STOT RE 2

Aquatic Chronic 1

H373 (teeth, bones)

H410

GHS08

GHS09

Wng

H373 (teeth, bones)

H410

 

M = 1’

 

‘604-099-00-7

4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF

216-036-7

1478-61-1

Repr. 1B

H360F

GHS08

Dgr

H360F’

 

 

 

‘604-100-00-0

nonylphenol, branched and linear, ethoxylated (with average molecular weight ≤ 1 540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof]

500-315-8

500-024-6

500-045-0

500-209-1

248-762-5

243-816-4

248-291-5

230-770-5 248-743-1 247-555-7 248-293-6

and others

127087-87-0

9016-45-9

26027-38-3

68412-54-4

27986-36-3

20427-84-3

27176-93-8

1119449-38-5 7311-27-5 27942-27-4 26264-02-8 27177-05-5 14409-72-4 and others

Aquatic Acute 1

Aquatic Chronic 1

H400

H410

GHS09

Wng

H410

 

M = 1

M = 10’

 

‘606-155-00-6

cinnamaldehyde; 3-phenylprop-2-enal;

cinnamic aldehyde; cinnamal; [1]

(2E)-3-phenylprop-2-enal [2]

203-213-9 [1] - [2]

104-55-2 [1] 14371-10-9 [2]

Skin Sens. 1A

H317

GHS07

Wng

H317

 

Skin Sens. 1; H317: C ≥ 0,01 %’

 

‘607-766-00-0

tetramethylene dimethacrylate

218-218-1

2082-81-7

Skin Sens. 1B

H317

GHS07

Wng

H317’

 

 

 

‘607-767-00-6

7,7,9(or 7,9,9)-trimethyl–4,13-dioxo–3,14-dioxa–5,12-diazahexadecane–1,16-diyl bismethacrylate

276-957-5

72869-86-4

Skin Sens. 1B

H317

GHS07

Wng

H317’

 

 

 

‘607-768-00-1

2,2'-ethylenedioxydiethyl dimethacrylate

203-652-6

109-16-0

Skin Sens. 1B

H317

GHS07

Wng

H317’

 

 

 

‘607-769-00-7

bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate

255-894-7

42576-02-3

Acute Tox. 4

Aquatic Acute 1

Aquatic Chronic 1

H302

H400

H410

GHS07

GHS09

Wng

H302

H410

 

oral:

ATE = 1 500 mg/kg bw

M = 1 000

M = 1 000 ’

 

‘612-295-00-9

benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

217-465-2

1861-40-1

Carc. 2

Repr. 2

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H351

H361d

H315

H319

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H361d

H315

H319

H317

H410

 

M = 10

M = 10’

 

‘612-296-00-4

N,N-dimethyl-p-toluidine

202-805-4

99-97-8

Carc. 1B

Acute Tox. 4

Acute Tox. 3

STOT RE 2

Aquatic Chronic 3

H350

H332

H301

H373 (blood system, respiratory tract)

H412

GHS08

GHS06

Dgr

H350

H332

H301

H373 (blood system, respiratory tract)

H412

 

inhalation:

ATE = 1,4 mg/L (dusts or mists)

oral:

ATE = 140 mg/kg bw’

 

‘612-297-00-X

1-phenylethan-1-one (1-phenylethylidene)hydrazone

211-979-0

729-43-1

Skin Sens. 1

H317

GHS07

Wng

H317’

 

 

 

‘612-298-00-5

1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.;

273-227-8

68953-84-4

Repr. 1B

Skin Sens. 1

H360FD

H317

GHS08

GHS07

Dgr

H360FD

H317’

 

 

 

‘613-346-00-8

4-nitrosomorpholine

59-89-2

Carc. 1B

Muta. 2

STOT RE 1

H350

H341

H372 (liver)

GHS08

Dgr

H350

H341

H372 (liver)

 

Carc. 1B; H350: C ≥ 0,001 %’

 

‘613-347-00-3

difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl–1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

119446-68-3

Carc. 2

Acute Tox. 4

Eye Irrit. 2

Aquatic Acute 1

Aquatic Chronic 1

H351

H302

H319

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H302

H319

H410

 

oral:

ATE = 1 450 mg/kg bw

M = 10

M = 10’

 

‘613-348-00-9

9-[2-(ethoxycarbonyl)phenyl]–3,6-bis(ethylamino)–2,7-dimethylxanthylium chloride; Basic Red 1

213-584-9

989-38-8

Acute Tox. 3

Eye Dam. 1

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H301

H318

H317

H400

H410

GHS06

GHS05

GHS09

Dgr

H301

H318

H317

H410

 

oral:

ATE = 280 mg/kg bw

M = 10

M = 1’

 

‘613-349-00-4

4-methylimidazole

212-497-3

822-36-6

Carc. 1B

Repr. 1B

H350

H360Fd

GHS08

Dgr

H350

H360Fd’

 

 

 

‘615-051-00-X

3,3'-dimethylbiphenyl–4,4'-diyl diisocyanate

202-112-7

91-97-4

Carc. 2

Resp. Sens. 1

Skin Sens. 1A

H351

H334

H317

GHS08

Dgr

H351

H334

H317

 

Skin Sens. 1A; H317: C ≥ 0,001 %’

 

‘616-241-00-5

foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea

173159-57-4

Carc. 2

Aquatic Acute 1

Aquatic Chronic 1

H351

H400

H410

GHS08

GHS09

Wng

H351

H410

 

M = 1 000

M = 100’

 

‘616-242-00-0

picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide

137641-05-5

STOT RE 2

Aquatic Acute 1

Aquatic Chronic 1

H373 (blood system, thyroid)

H400

H410

GHS08

GHS09

Wng

H373 (blood system, thyroid)

H410

 

M = 1 000

M = 1 000 ’

 

(2)

the entries corresponding to index numbers 006-015-00-9; 015-203-00-X; 016-001-00-4; 016-011-00-9; 017-004-00-3; 017-005-00-9; 082-013-00-1; 082-014-00-7; 603-057-00-5; 604-010-00-1; 604-074-00-0; 606-034-00-8; 607-032-00-X; 607-034-00-0; 607-223-00-8; 607-246-00-3; 612-004-00-5; 612-049-00-0; 612-056-00-9; 613-088-00-6; 613-127-00-7; 613-307-00-5; 616-035-00-5; 616-104-00-X are replaced by the following entries respectively:

Index No

Chemical Name

EC No

CAS No

Classification

Labelling

Specific Conc. Limits, M-factors and ATE

Notes

Hazard Class and Category Code(s)

Hazard statement Code(s)

Pictogram, Signal Word Code(s)

Hazard statement Code(s)

Suppl. Hazard statement Code(s)

‘006-015-00-9

diuron (ISO); 3-(3,4-dichlorophenyl)–1,1-dimethylurea

206-354-4

330-54-1

Carc. 1B

STOT RE 2

Aquatic Acute 1

Aquatic Chronic 1

H350

H373 (blood system)

H400

H410

GHS08

GHS09

Dgr

H350

H373 (blood system)

H410

 

M = 100

M = 100’

 

‘015-203-00-X

diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide

278-355-8

75980-60-8

Repr. 1B

Skin Sens. 1B

H360Fd

H317

GHS08

GHS07

Dgr

H360Fd

H317’

 

 

 

‘016-001-00-4

hydrogen sulphide, hydrogen sulfide

231-977-3

7783-06-4

Flam. Gas 1A

Press. Gas

Acute Tox. 2

Aquatic Acute 1

H220

H330

H400

GHS02

GHS06

GHS09

Dgr

H220

H330

H400

 

inhalation: ATE = 440 ppmV (gases)

U’

‘016-011-00-9

sulphur dioxide; sulfur dioxide

231-195-2

7446-09-5

Press. Gas

Acute Tox. 3

STOT SE 1

Skin. Corr. 1B

H331

H370 (respiratory system) (inhalation)

H314

GHS04

GHS06

GHS08

GHS05

Dgr

H331

H370 (respiratory system) (inhalation)

H314

 

inhalation: ATE = 1 000 ppmV (gases)

U, 5’

‘017-004-00-3

potassium chlorate

223-289-7

3811-04-9

Ox. Sol. 1

Acute Tox. 3

H271

H301

GHS03

GHS06

Dgr

H271

H301

 

oral: ATE = 100 mg/kg bw’

 

‘017-005-00-9

sodium chlorate

231-887-4

7775-09-9

Ox. Sol. 1

Acute Tox. 3

H271

H301

GHS03

GHS06

Dgr

H271

H301

 

oral: ATE = 100 mg/kg bw’

 

‘082-013-00-1

lead powder;

[particle diameter < 1 mm]

231-100-4

7439-92-1

Repr. 1A

Lact.

Aquatic Acute 1

Aquatic Chronic 1

H360FD

H362

H400

H410

GHS08

GHS09

Dgr

H360FD

H362

H410

 

Repr. 1A;

H360D: C ≥ 0,03 %

M = 10

M = 100’

 

‘082-014-00-7

lead massive:

[particle diameter ≥ 1 mm]

231-100-4

7439-92-1

Repr. 1A

Lact.

Aquatic Chronic 1

H360FD

H362

H410

GHS08

GHS09

Dgr

H360FD

H362

H410

 

M = 10’

 

‘603-057-00-5

benzyl alcohol

202-859-9

100-51-6

Acute Tox. 4

Eye Irrit. 2

Skin Sens. 1B

H302

H319

H317

GHS07

Wng

H302

H319

H317

 

oral: ATE = 1 200 mg/kg bw’

 

‘604-010-00-1

resorcinol; 1,3-benzenediol

203-585-2

108-46-3

Acute Tox. 4

STOT SE 1

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1B

Aquatic Acute 1

H302

H370 (nervous system)

H315

H319

H317

H400

GHS07

GHS08

GHS09

Dgr

H302

H370 (nervous system)

H315

H319

H317

H400

 

oral: ATE = 500 mg/kg bw

M = 1’

 

‘604-074-00-0

2,2',6,6'-tetrabromo–4,4'-isopropylidenediphenol; tetrabromobisphenol-A

201-236-9

79-94-7

Carc. 1B

Aquatic Acute 1

Aquatic Chronic 1

H350

H400

H410

GHS08

GHS09

Dgr

H350

H410’

 

 

 

‘606-034-00-8

metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one

244-209-7

21087-64-9

Acute Tox. 4

STOT RE 2

Aquatic Acute 1

Aquatic Chronic 1

H302

H373 (blood system)

H400

H410

GHS07

GHS08

GHS09

Wng

H302

H373 (blood system)

H410

 

oral: ATE = 320 mg/kg bw

M = 10

M = 10’

 

‘607-032-00-X

ethyl acrylate

205-438-8

140-88-5

Flam. Liq. 2

Acute Tox. 3

Acute Tox. 4

Acute Tox. 4

STOT SE 3

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

H225

H331

H312

H302

H335

H315

H319

H317

GHS02

GHS06

Dgr

H225

H331

H312

H302

H335

H315

H319

H317

 

inhalation: ATE = 9 mg/L (vapours)

dermal: ATE = 1 800 mg/kg bw

oral: ATE = 1 120 mg/kg bw

STOT SE 3; H335: C ≥ 5 %

Skin Irrit. 2; H315: C ≥ 5 %

Eye Irrit. 2; H319: C ≥ 5 %

D’

‘607-034-00-0

methyl acrylate;

methyl propenoate

202-500-6

96-33-3

Flam. Liq. 2

Acute Tox. 3

Acute Tox. 4

Acute Tox. 4

STOT SE 3

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

H225

H331

H312

H302

H335

H315

H319

H317

GHS02

GHS06

Dgr

H225

H331

H312

H302

H335

H315

H319

H317

 

inhalation: ATE = 3 mg/L (vapours)

dermal: ATE = 1 100 mg/kg bw

oral: ATE = 500 mg/kg bw

D’

‘607-223-00-8

transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

405-060-5

118712-89-3

Carc. 2

Acute Tox. 4

STOT SE 1

Aquatic Acute 1

Aquatic Chronic 1

H351

H302

H370 (nervous system)

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H302

H370 (nervous system)

H410

EUH066

oral: ATE = 580 mg/kg bw

M = 1 000

M = 1 000 ’

 

‘607-246-00-3

allyl methacrylate;

2-methyl-2-propenoic acid 2-propenyl ester

202-473-0

96-05-9

Flam. Liq. 3

Acute Tox. 2

Acute Tox. 3

Acute Tox. 4

Aquatic Acute 1

H226

H330

H311

H302

H400

GHS02

GHS06

GHS09

Dgr

H226

H330

H311

H302

H400

 

inhalation: ATE = 1,5 mg/L (vapours)

dermal: ATE = 300 mg/kg bw

oral: ATE = 400 mg/kg bw’

 

‘612-004-00-5

triethylamine

204-469-4

121-44-8

Flam. Liq. 2

Acute Tox. 3

Acute Tox. 3

Acute Tox. 3

Skin Corr. 1A

Eye Dam. 1

H225

H331

H311

H301

H314

H318

GHS02

GHS06

GHS05

Dgr

H225

H331

H311

H301

H314

 

inhalation: ATE = 7,2 mg/L (vapours)

dermal: ATE = 300 mg/kg bw

oral: ATE = 100 mg/kg bw STOT SE 3; H335: C ≥ 1 %’

 

‘612-049-00-0

di-n-butylamine

203-921-8

111-92-2

Flam. Liq. 3

Acute Tox. 2

Acute Tox. 3

Acute Tox. 3

Skin Corr. 1B

Eye Dam. 1

H226

H330

H311

H301

H314

H318

GHS02

GHS06

GHS05

Dgr

H226

H330

H311

H301

H314

EUH 071

inhalation: ATE = 1,2 mg/L (vapours) dermal: ATE = 300 mg/kg bw

oral: ATE = 220 mg/kg bw’

 

‘612-056-00-9

N,N-dimethyl-m-toluidine; [1]

N,N-dimethyl-o-toluidine [2]

204-495-6 [1] 210-199-8 [2]

121-72-2 [1] 609-72-3 [2]

Acute Tox. 3 * Acute Tox. 3 * Acute Tox. 3 * STOT RE 2 * Aquatic Chronic 3

H331

H311

H301

H373 **

H412

GHS06 GHS08

Dgr

H331

H311

H301

H373 **

H412

 

*

C’

‘613-088-00-6

1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one

220-120-9

2634-33-5

Acute Tox. 2

Acute Tox. 4

Skin Irrit. 2

Eye Dam. 1

Skin Sens. 1A

Aquatic Acute 1

Aquatic Chronic 1

H330

H302

H315

H318

H317

H400

H410

GHS06

GHS05

GHS09

Dgr

H330

H302

H315

H318

H317

H410

 

inhalation:

ATE = 0,21 mg/L (dusts or mists)

oral: ATE = 450 mg/kg bw

Skin Sens. 1A; H317: C ≥ 0,036 %

M = 1

M = 1’

 

‘613-127-00-7

mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride

246-147-6

24307-26-4

Acute Tox. 4

Acute Tox. 3

Aquatic Chronic 3

H332

H301

H412

GHS06

Dgr

H332

H301

H412

 

inhalation: ATE = 2,8 mg/L (dusts or mists)

oral:

ATE = 270 mg/kg bw’

 

‘613-307-00-5

clothianidin (ISO); (E)-1-(2-chloro–1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

433-460-1

210880-92-5

Repr. 2

Acute Tox. 4

STOT SE 1

Aquatic Acute 1

Aquatic Chronic 1

H361f

H302

H370 (nervous system)

H400

H410

GHS08

GHS07

GHS09

Dgr

H361f

H302

H370 (nervous system)

H410

 

oral: ATE = 390 mg/kg bw

M = 10

M = 100’

 

‘616-035-00-5

cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [1]

(2E)-2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [2]

261-043-0 [1]

- [2]

57966-95-7 [1]

166900-80-7 [2]

Repr. 2

Acute Tox. 4

STOT RE 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H361fd

H302

H373 (blood system, thymus, eyes)

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H361fd

H302

H373 (blood system, thymus, eyes)

H317

H410

 

oral: ATE = 360 mg/kg bw

M = 1

M = 1’

 

‘616-104-00-X

benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate

275-728-7

71626-11-4

Acute Tox. 4

Aquatic Acute 1

Aquatic Chronic 1

H302

H400

H410

GHS07

GHS09

Wng

H302

H410

 

oral: ATE = 1 000 mg/kg bw

M = 1

M = 1’

 


ELI: http://data.europa.eu/eli/reg_del/2024/197/oj

ISSN 1977-0677 (electronic edition)


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